Head Cancer NeckIReC-BioNCT05885490
IReC-Bio and IReC Registry
An observational study of Head Cancer Neck, run by Royal Marsden NHS Foundation Trust.
Trial summary
IReC is the world's first centre for recurrent head and neck cancers. We have the ambitious aim to create a centre of international excellence and set international standards in the curative treatment of recurrent head and neck cancers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head Cancer Neck
- How many people
- 10,000,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck
Who may be able to join
- Aged over 18 at time of diagnosis.
- Confirmed clinical, radiological, and/ or histological diagnosis of residual, recurrent, or new primary malignant head and neck cancer arising from the nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, sinonasal cavities, major salivary glands and thyroid gland.
- Any mucosal, salivary gland, and thyroid histological subtype
- Ability to give informed consent.
- Details of clinical follow-up available
- For IReC-BIO only:
Show all 10Show fewer
- FFPE blocks(s) or fresh frozen tumour tissue available for collection
- Two or more tumour-containing blocks available from the same specimen
- For QoL Questionnaires only:
- Patients who have received a diagnosis of rHNC no earlier than 6 weeks prior to study entry
Who cannot join
- Recurrent cutaneous (e.g., SCC, melanoma), sarcomatous, and lymphatic or haematological (e.g. lymphoma) malignancies of the head and neck
- For IReC-BIO only:
- FFPE tumour samples contain insufficient tumour sample for analysis.
- Insufficient clinical details available
- For QoL Questionnaires only:
- Patients who have received a diagnosis of rHNC more than 6 weeks prior to study entry
About this study
Official title: Protocol for The International Centre for Recurrent Head and Neck Cancer (IReC) Tissue Biobank and Data Registry
IReC is the world's first centre for recurrent head and neck cancers. We have the ambitious aim to create a centre of international excellence and set international standards in the curative treatment of recurrent head and neck cancers.
One of IReC's key objectives is to develop a national research tissue bank to support laboratory and translational research. The cornerstone of translational research is a well-annotated biobank of cancer samples to explore and validate key research findings.
Read more
The purpose of IReC-Bio is to support research into recurrent head and neck cancers. A central repository for the rarer recurrent cancers will allow the concentration of cases required in order to support translational research programmes. The overall aim is to facilitate research into understanding disease biology, identifying potentially curative treatments, and allow detailed investigations into the relationships between clinical, pathological and molecular characteristics and clinical outcomes.
Combining the IReC Registry and Biobank gives us a comprehensive data and sample set which has never been created before for recurrent head and neck cancer. The aim is to have a national, and in the future international, resource of the study of recurrent head and neck cancer on a molecular and clinical level to support novel ways of treating rHNC.
Read the detailed description
There are currently only a limited number of proven treatments for use in cancers of the head and neck, and a better understanding of the biology of different HNCs could lead to improved therapies. Although many patients with head and neck cancer can be offered potentially curative treatment, we do not understand why some people are cured and others are not. There has been an explosion in molecular research in many cancers, but this remains an understudied area in head and neck cancer. There are currently no treatments available to patients with head and neck cancer based on molecular characteristics.
The purpose of IReC-BIO is to support research into rHNCs. A central repository for the rarer recurrent cancers will allow the concentration of cases required in order to support translational research programmes. The overall aim is to facilitate research into understanding disease biology, identifying potentially curative treatments, and allow detailed investigations into the relationships between clinical, pathological and molecular characteristics and clinical outcomes.
Cancer registries store large quantities of data from defined cancer populations. Registry aims vary, but include analysing cancer trends over time and supplying data for research studies5-7. The NCDB and SEER are extensively studied registries, producing >200 publications per year6. Both provide a broad overview of all major cancers; however, they have notable datapoint gaps, in particular, recurrence and patient reported outcome measures (PROMs).
Establishing a cancer registry necessitates a balance of clinical, informatic, and financial influences. Cancer registry development is subject to numerous pitfalls, ranging from excessive datapoints to inadequate quality assurance7. These can be mitigated through adherence to best practice recommendations, for example the NAACCR and ENCR, which provide guidelines that standardise registry datasets8,9. However, not all recommendations are practical across all cancer diagnoses. In particular, rHNC requires a tailored approach to document the treatment and functional implications unique to this cohort, necessitating development of a registry specific to this disease.
- Conditions
- Head Cancer Neck
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data only | |
| Group 2 | Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional biobank sampling | |
| Group 3 | Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional quality of life data | |
| Group 4 | Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional quality of life data and optional biobank sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the 2 year overall survival rates in all patients with rHNC
2-year overall survival from date of diagnosis
Measured: 2 years
Secondary outcomes (3)
Define the 2-year disease-free (DFS), disease-specific (DSS), and local recurrence free survival (LRFS) rates in all patients with rHNC.
2 year disease free survival, disease specific and local recurrence free survival rates in all patients with rHNC
Measured: 2 years
Define long-term functional outcomes after diagnosis of rHNC using gastrostomy and tracheostomy use as a surrogate marker up to 2 years after diagnosis with rHNC
1 and 2-year gastrostomy and tracheostomy status from date of diagnosis
Measured: 2 years
Assess swallow with Performance Status Scale for head and neck cancer patients (PSS-HN) scores up to 2 years after diagnosis of rHNC.
Entry, 6, 12 and 24-month PSS-HN NOD scores
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study startApr 2026 (estimated)
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Cancer NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885490
- Sponsor's protocol ID
- 5604
- Acronym
- IReC-Bio
- Status last verified
- Feb 2026
- First submitted
- 3 May 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for The International Centre for Recurrent Head and Neck Cancer (IReC) Tissue Biobank and Data Registry
- ClinicalTrials.gov ID
- NCT05885490
- Acronym / sponsor ID
- IReC-Bio / 5604
- Conditions
- Head Cancer Neck
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000,000 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
IReC is the world's first centre for recurrent head and neck cancers. We have the ambitious aim to create a centre of international excellence and set international standards in the curative treatment of recurrent head and neck cancers.
One of IReC's key objectives is to develop a national research tissue bank to support laboratory and translational research. The cornerstone of translational research is a well-annotated biobank of cancer samples to explore and validate key research findings.
The purpose of IReC-Bio is to support research into recurrent head and neck cancers. A central repository for the rarer recurrent cancers will allow the concentration of cases required in order to support translational research programmes. The overall aim is to facilitate research into understanding disease biology, identifying potentially curative treatments, and allow detailed investigations into the relationships between clinical, pathological and molecular characteristics and clinical outcomes.
Combining the IReC Registry and Biobank gives us a comprehensive data and sample set which has never been created before for recurrent head and neck cancer. The aim is to have a national, and in the future international, resource of the study of recurrent head and neck cancer on a molecular and clinical level to support novel ways of treating rHNC.
Detailed description
There are currently only a limited number of proven treatments for use in cancers of the head and neck, and a better understanding of the biology of different HNCs could lead to improved therapies. Although many patients with head and neck cancer can be offered potentially curative treatment, we do not understand why some people are cured and others are not. There has been an explosion in molecular research in many cancers, but this remains an understudied area in head and neck cancer. There are currently no treatments available to patients with head and neck cancer based on molecular characteristics.
The purpose of IReC-BIO is to support research into rHNCs. A central repository for the rarer recurrent cancers will allow the concentration of cases required in order to support translational research programmes. The overall aim is to facilitate research into understanding disease biology, identifying potentially curative treatments, and allow detailed investigations into the relationships between clinical, pathological and molecular characteristics and clinical outcomes.
Cancer registries store large quantities of data from defined cancer populations. Registry aims vary, but include analysing cancer trends over time and supplying data for research studies5-7. The NCDB and SEER are extensively studied registries, producing >200 publications per year6. Both provide a broad overview of all major cancers; however, they have notable datapoint gaps, in particular, recurrence and patient reported outcome measures (PROMs).
Establishing a cancer registry necessitates a balance of clinical, informatic, and financial influences. Cancer registry development is subject to numerous pitfalls, ranging from excessive datapoints to inadequate quality assurance7. These can be mitigated through adherence to best practice recommendations, for example the NAACCR and ENCR, which provide guidelines that standardise registry datasets8,9. However, not all recommendations are practical across all cancer diagnoses. In particular, rHNC requires a tailored approach to document the treatment and functional implications unique to this cohort, necessitating development of a registry specific to this disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data only |
| Group 2 | – | –Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional biobank sampling |
| Group 3 | – | –Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional quality of life data |
| Group 4 | – | –Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional quality of life data and optional biobank sampling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck
Key inclusion criteria (10 listed)
- Aged over 18 at time of diagnosis.
- Confirmed clinical, radiological, and/ or histological diagnosis of residual, recurrent, or new primary malignant head and neck cancer arising from the nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, sinonasal cavities, major salivary glands and thyroid gland.
- Any mucosal, salivary gland, and thyroid histological subtype
- Ability to give informed consent.
- Details of clinical follow-up available
Key exclusion criteria (6 listed)
- Recurrent cutaneous (e.g., SCC, melanoma), sarcomatous, and lymphatic or haematological (e.g. lymphoma) malignancies of the head and neck
- FFPE tumour samples contain insufficient tumour sample for analysis.
- Insufficient clinical details available
- Patients who have received a diagnosis of rHNC more than 6 weeks prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Define the 2 year overall survival rates in all patients with rHNC
Time frame: 2 years
2-year overall survival from date of diagnosis
3 secondary outcomes
Define the 2-year disease-free (DFS), disease-specific (DSS), and local recurrence free survival (LRFS) rates in all patients with rHNC.
Time frame: 2 years
Define long-term functional outcomes after diagnosis of rHNC using gastrostomy and tracheostomy use as a surrogate marker up to 2 years after diagnosis with rHNC
Time frame: 2 years
Assess swallow with Performance Status Scale for head and neck cancer patients (PSS-HN) scores up to 2 years after diagnosis of rHNC.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Cancer Neck, run by Royal Marsden NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the 2 year overall survival rates in all patients with rHNC (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.